Apollo Overstitch, a Treat and Resect Model

Not Applicable

Completed

Conditions: Colon Benign Tumor
Colon Malignant Tumor

Interventions: Device: Overstitch Endoscopic Suturing System

Registration Number: NCT01307813

Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary: The Overstitch (Apollo Endosurgery, Austin, Texas) is an FDA cleared product which attaches to a standard double channel endoscope. The Overstitch can place sutures under endoscopic guidance, with the goal of reproducing standard surgical techniques. These would include hemostasis, tissue approximation, anastomosis formation, fixation of intraluminal devices, or repair/closure of mucosal or full thickness defects such as perforations or endoscopic mucosal resection (EMR) sites. Knot tying of the endoscopically placed sutures is provided by an endoscopic cinching device that passes through the channel of the endoscope.

This feasibility trial will evaluate the ability of the Apollo suturing device (Overstitch) to endoscopically place sutures into normal mucosa, and then "tie" the sutures with the cinching device. These devices have been utilized effectively in explant, live porcine, and human cadaver colon and stomach models. In this treat and resect model, sutures would be placed in a segment of colon or stomach that is being surgically removed via open or laparoscopic technique for the treatment of benign or malignant disease. The sutures would be placed in a segment of normal mucosa remote to the pathology being surgically treated. In addition, the sutures will be placed under direct observation via laparoscopic or open visualization. After resection of the segment of colon, it will be evaluated grossly for level of suture placement, evidence of perforation, and quality of suture approximation with the cinching device.

Detailed Description: During the colectomy procedure, the intended proximal and distal margins of resection will be determined, and the protocol will proceed only if it is fully determined that the tissue will be fully resectable. The overstitch device affixed to a standard double channel gastroscope will then be advanced transanally into the segment of planned resected colon, away from the area of disease so as to not interfere with oncologic principles or post-resection pathologic evaluation. Endoscopic sutures and knot tying cinching elements will be placed, with a limit of 15 minutes for the total procedure. The entire procedure will be closely monitored under laparoscopic or open surgical visualization. After suture placement, the surgical resection will continue as planned. The specimen will then be examined for depth of suture placement, evidence of perforation, and quality of the suture approximation with the knot tying element.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4

Inclusion Criteria

The patient population in this study will be candidates of either sex, over 18' who have an established indication for a surgical procedure requiring resection of a portion of colon distal to the splenic flexure. This will include both benign and malignant diseases.

Exclusion Criteria

Any underlying pathology in the determination of investigator that subject cannot undergo scoping
Sutures cannot be placed in segment of bowel that will be included in the surgical resection
Pregnant women will be excluded from participating in this protocol

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic suturing device	Overstitch Endoscopic Suturing System	Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.

Primary Outcome Measures

Name	Time	Method
Successful Suture Approximation With Cinching Device	Approximately 1 hour post resection of the colon in surgery	Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area. When two tissue bites were taken within an individual stitch, the quality of mucosal approximation was graded on a four-point Likert scale (1 = Poor, 2 = Good, 3 = Very Good, 4 = Excellent).

Secondary Outcome Measures